Tag: FDA
Army Scientists’ Technique for Early Sepsis Detection in Burn Patients Submitted to FDA
A new invention developed at the U.S. Army Medical Research and Development Command uses an artificial intelligence machine learning algorithm to identify whether burn patients are at risk of experiencing life-threatening... read more
BARDA Selected Host-directed Therapeutic Candidates to Address ARDS
Biomedical Advanced Research and Development Authority (BARDA) has selected host-directed therapeutic candidates for inclusion in a phase 2 platform clinical trial to address acute respiratory distress syndrome (ARDS). Currently,... read more
ReddyPort Non-Invasive Ventilation Device Cleared By FDA
ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV). "ReddyPort's patented elbow is central... read more
Adapting FDA Regulation for AI-Powered Medical Devices
To keep up with the advancement of medical technology, the FDA has been working on a digital health pre-certification program that would allow the agency to pre-approve trusted manufacturers to update their software products.... read more
The Role of Antiviral Treatment in the COVID-19 Pandemic
US Food and Drug Administration (FDA) issued an emergency use authorisation for Pfizer's COVID-19 antiviral, Paxlovid few weeks ago. Trial results released by the manufacturer indicate that the drug cuts the risk of hospitalisation... read more
Clinical Trials Design Evaluating Sedation in Critically Ill Adults Requiring Mechanical Ventilation
These recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who... read more
Understanding The Links Between COVID-19 Vaccines and Thrombosis
The Advisory Committee on Immunization Practices (ACIP) is convening an emergency meeting to discuss adverse events that recently led to thrombotic events in 6 women administered the Johnson & Johnson COVID-19 vaccine in... read more
NeuroRx Announced Completion of Data Analysis for COVID-19 Treatment Respiratory Failure
NeuroRx, Inc. announced completion of top line data analysis of the 60-day results in its phase 2b/3 clinical trial, conducted under FDA Fast Track Designation, of ZYESAMI™ (aviptadil acetate) for the treatment of critically-ill... read more
Cerecor Significantly Reduced Respiratory Failure and Mortality in Phase 2 Clinical Trial in Patients Hospitalized with COVID-19 ARDS
Final analysis inclusive of the 60-day safety update in the randomized placebo-controlled study demonstrated CERC-002 was statistically significant in reducing respiratory failure and mortality at Day 28 in patients hospitalized... read more
How can artificial intelligence transform pneumonia diagnosis?
Hot on the heels of FDA approval for its AI-guided cardiac ultrasound software, Caption has received a $4.95m grant from the Gates Foundation to create a version that could speed up pneumonia diagnosis, the leading killer... read more
FDA Limits Use of Convalescent Plasma as COVID-19 Treatment
The Food and Drug Administration (FDA) is scaling back its authorization of the use of convalescent blood-plasma for COVID-19 patients in an effort to guide physicians who have faced a confusing thicket of data about the... read more
Allergic Reactions After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine
Early safety monitoring of the Pfizer-BioNTech COVID-19 vaccine has detected 21 cases of anaphylaxis after reported administration of 1,893,360 first doses of Pfizer-BioNTech COVID-19 vaccine (11.1 cases per million vaccine... read more
The Risk of False Negative Results with the Curative COVID-19 Test
The U.S. Food and Drug Administration (FDA) is alerting patients and health care providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. Risks to a patient of a... read more
FDA Authorized First Point-of-Care Antibody Test for COVID-19
U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for... read more
FDA Approves New Pill to Treat Sickle Cell Disease
The Food and Drug Administration on Monday approved a once-daily pill for sickle cell disease that works in an entirely new way — by boosting hemoglobin, the oxygen-carrying molecule found in red blood cells. The novel... read more
Hospitals Delay Use Of New Antibiotics
According to a new study published in Diagnostic Microbiology and Infectious Disease, US hospitals on average waited more than a year to prescribe any of six new antibiotics approved by the US Food and Drug Administration... read more
3 Notable Leaps in Sepsis Care
Sepsis is deadly, it's expensive, and there are abundant initiatives underway that could lead to earlier detection, lowering costs, and saving lives. In May 2016, the Healthcare Cost and Utilization Project and the Agency... read more
